It is well known that medicaments are provided in sealed containers such as glass vials, often with a rubber stopper or seal which can be penetrated with a syringe and needle assembly to obtain access to the contents. There are many instances when the medicaments are withdrawn from the vial or other container and are then directly injected into the patient. Some injections are given intravenously directly while other are given subcutaneously or intramuscularly. In each case, the injection is given with a sharp, pointed needle which is designed to penetrate into the patient with as little stress and discomfort as possible.
Of course, this is not the only method for providing and dispensing medicaments. Bottles and caps are used for dispensing pills, powders and the like. However, often times the medicament is injected into the patient by a means which is already invasive such as conventional IV systems where fluids are drained into an apparatus which includes a needle which has already been inserted into the patient. Blood, plasma, glucose and other fluids are conventionally given to patients in this manner. The bag of fluid being administered is connected to the system which has already been connected to the patient. Also heparin locks are uniformly used on patients in hospitals and heparin or saline solutions are injected into the heparin lock on a regular basis.
Oftentimes, it is desirable to add specified medicaments to IV systems and other patient treating systems such as catheter type implants. This is done by withdrawing the medicament from the container in which it is supplied, followed by transfer to the system. Most often, syringes are also used to withdraw the medicament even though syringes are not the most easy devices to safely and successfully transfer fluids from one sealed container to a system for use. Of primary concern, of course, is loss of fluid from leakage or spillage from the needle. Another concern is that the medical professional using the syringe and needle will inadvertently contact the sharp point of the needle, either on the patient or on the professional, causing inappropriate transfer of the contents of the syringe.
Various systems have been proposed to transfer medicaments and the like from a container using something other than a syringe and needle. For example, Adams, et al U.S. Pat. No. 2,689,562 provides for an assembly for use with blood donation and transfer. This system employs a needle which is enclosed in a rubber sheath which is aligned with an opening in a stopper so that the needle penetrates a reduced section of the stopper.
One proposal which has been found in the prior art is to provide a stopper which can be penetrated by a cannula which is not sharp like a needle. Examples of designs for providing access to a container in this manner are shown in Breakstone U.S. Pat. No. 2,579,724, Zackbeim U.S. Pat. No. 3,823,840 and Handman U.S. Pat. No. 4,244,478. Each of these designs provides a stopper with a slit extending entirely through the stopper. The slit is normally closed and provides access to the contents when the closed sides of the slit are forced apart. Breakstone U.S. Pat. No. 2,579,724 employs a tube which is forced through an opening in a cap. Zackbeim U.S. Pat. No. 3,823,840 employs an arcuate slit made in an elastomeric member so that the slit is intended to reseal itself after it is punctured with a plastic cannula. Handman U.S. Pat. No. 4,244,478 discloses an annular rim which at least partially covers a self-venting, self-resealing linear slit valve. The slit valve is protected by a sealing ring which has to be released to allow removal of the contents of the container.
In an unrelated art, Gunne et al U.S. Pat. No. 4,243,150 discloses a bottle seal for use with automatic ink dispensing systems. In this design, a stopper is disclosed which has a cross shaped slit which is covered with foil and an overlying disk which also has a cross shaped slit. Access to the contents is obtained through the first slit, through the foil and then through the second slit.
Another prior art design which relates generally to orally administered medications and the like is shown in two patents to Finkelstein, U.S. Pat. Nos. 4,420,092 and 4,449,640. These patents describe a tamper resistant pharmaceutical vial and cap assembly which is designed for unit dose oral administration of pharmaceuticals while maintaining the vial effectively closed prior to filing. The cap is intended for use with what is said to be a conventional blunt fill needle of the type used in the filling of back-fill syringes and vials. This blunt fill needle penetrates an open hole which is then closed with a stopper that snap fits into place.
At the present time, none of the prior art devices disclose a system using a stopper which is effective for pharmaceutical products and which is sealed well enough to meet industry standards while allowing the use of something other than a sharp needle. A typical stopper design is shown in Wimmer U.S. Pat. No. 3,653,523. In this patent, an improved stopper is shown with a conical indentation terminating in a central apex through which a needle is to be inserted. The improvement is described as preventing or substantially reducing "coring" and other problems, and is a design still in use today in systems where sharp pointed needles are employed.
As will be noted, none of these prior art devices provide a full and complete seal of a container which has medicaments as contents and to which access is sought without resorting to a sharp needle and syringe device. Accordingly, it is an object of the present invention to provide a vial and closure assembly which can be used without a sharp pointed needle.
Accordingly, an object of this invention is to provide a closure assembly which can be accessed by a sharp needle as well as a blunt needle like device. This provides a system that offers computability with current hospital practice as well as with more recent blunt cannula system.
Another object of this invention is to provide a device which is safely sealed from outside contamination and which is suitable for use with a blunt instrument to permit insertion of such an instrument and obtain access to the contents.
Yet another object of the present invention is to provide a closure in the form of a stopper for vials and other containers which can be used with blunt needle-like instruments to withdraw the contents of the bottle to transfer the contents for use in other devices.
Other objects will appear hereinafter.